MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH TIB ROT COMP XS-XL; prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

Catalog Number	64812100
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat#: unknown; unknown bushing 1 of 2; lot#: unknown.Cat#: unknown; unknown bushing 2 of 2; lot#: unknown.Cat#: unknown; unknown sleeve; lot#: unknown.Cat#: unknown; unknown axle; lot#: unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The following information was provided: revision knee surgery - infection.

• Brand Name: MRH TIB ROT COMP XS-XL
• Common Device Name: prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): Stryker Orthopaedics-Limerick; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24870050
• Report Number: 0002249697-2026-00284
• Device Sequence Number: 9081690
• Product Code: KRO
• UDI-Device Identifier: 07613327045208
• UDI-Public: 07613327045208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 64812100
• Device Lot Number: 226394D
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female